NCT00441987

Brief Summary

The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 3, 2022

Status Verified

June 1, 2010

Enrollment Period

2.4 years

First QC Date

February 28, 2007

Last Update Submit

April 28, 2022

Conditions

Healthy

Keywords

JapaneseHealthyAlzheimers Disease

Outcome Measures

Primary Outcomes (1)

  • Number of participants reporting Adverse Event

    Safety

    10 months

Study Arms (1)

Single Dose of GSI-953

EXPERIMENTAL
Drug: GSI-953

Interventions

GSI-953DRUG
Single Dose of GSI-953

Eligibility Criteria

Age20 Years - 120 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Healthy males aged 20 - 40 and healthy males aged greater than 65. * Body mass index range of 17.6 - 26.4 kg/m2 greater than or equal to 45 kg. * Non-smokers or smoker of fewer than 10 cigarettes a day.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kitashinagawa, Shinagawa-ku, 141-0001, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 1, 2007

Study Start

February 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 3, 2022

Record last verified: 2010-06

Locations

JP(1)